The aim of our study was to assay and compare the effect of CO2 laser ablation therapy with respect to topical corticosteroids in the treatment of symptomatic oral lichen planus.
In this interventional clinical trial study, patients with symptomatic oral lichen planus(OLP) that refer to Oral Medicine Department of Faculty of Dentistry of Shiraz Medical Sciences evaluated accurately. patients with positive clinical and histopathological verification enter to study .Those who were pregnant or who had a history of systemic disease were excluded. Finally, thirty six patients were randomly allocated into two groups. 18 patients allocate in interventional group(laser group) and 18 patients allocate in control group(corticosteroid group) . The interventional group treated by CO2 laser and the control group used Dexamethasone mouthwash 0.1% as topical steroid. For laser group used CO2 laser ablation therapy at 4 consecutive section during 2weeks and each lesion with at least 2-3mm of normal borders abladed. Control group used 3 times daily topical steroid in affected sites for 4 weeks. Each patient of both groups followed 2months after last treatment. Visual Analogue Scale (VAS) for pain and burning sensation and Thongprasom criteria(for size and type change) used for treatment evaluation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104286322N1
Registration date:2013-07-06, 1392/04/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-06, 1392/04/15
Registrant information
Name
Mostafa Rezaee
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1635 6681
Email address
rezaim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-01-01, 1389/10/11
Expected recruitment end date
2011-06-14, 1390/03/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of CO2 laser therapy with respect to topical corticosteroid for treatment of oral lichen planus
Public title
Comparison the effect of CO2 laser therapy with respect to topical corticosteroid for treatment of oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with symptomatic oral lichen planus that refer to oral medicine department of faculty of dentistry of Shiraz Medical Sciences that clinical and histopathological data confirm this diagnosis
Exclusion criteria : pregnancy; systemic disease;oral lesion close to amalgam filling ; lesions that is treat by other treatments
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz Medical Ethics Committee
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street. Shiraz, Fras , Iran
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
CT-89-5476
Health conditions studied
1
Description of health condition studied
oral lichen planus
ICD-10 code
L43
ICD-10 code description
Lichen planus
Primary outcomes
1
Description
pain and burning sensation score
Timepoint
4 section during 2 week
Method of measurement
VAS criteria
2
Description
size and type of lesion
Timepoint
4 section during 2weeks
Method of measurement
ruler measurement and Thongprasom criteria
Secondary outcomes
empty
Intervention groups
1
Description
interventional group: CO2 laser ablation therapy on standard protocol (power 4w,2 J/Cm2 ,frequency 80Hz,Pulse Mode, straight Tip, defocused mode and non-contact) at 4 section during 2 week and at least 2-3mm of normal borders abladed
Category
Treatment - Other
2
Description
control group : used dexamethasone mouthwash 0.1% as topical steroid 3 times daily in affected sites for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mostafa Rezaee
Street address
Oral medcine department, Faculty of Dentistry of Shiraz University of Medical Sciences, Ghasr o dasht street , Shiraz , Fars, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Scinces
Full name of responsible person
Dr. Mostafa Rezaee
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street. Shiraz, Fras , Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Scinces
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Scinces
Full name of responsible person
Dr. Mostafa Rezaee
Position
DMD of Oral and Maxillofacial Medicine
Other areas of specialty/work
Street address
Oral medcine department, Faculty of Dentistry of Shiraz University of Medical Sciences, Ghasr o dasht street , Shiraz , Fars, Iran
City
Shiraz
Postal code
Phone
+98 71 1628 9917
Fax
Email
rezaim@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Scinces
Full name of responsible person
Dr. Dariush Amanat
Position
DMD of Oral and Maxillofacial medicine
Other areas of specialty/work
Street address
Oral medcine department, Faculty of Dentistry of Shiraz University of Medical Sciences, Ghasr o dasht street , Shiraz , Fars, Iran
City
Shiraz
Postal code
Phone
+98 71 1628 9917
Fax
Email
amanatd@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Scinces
Full name of responsible person
Dr. Mostafa Rezaee
Position
DMD of Oral and Maxillofacial medicine
Other areas of specialty/work
Street address
Oral medcine department, Faculty of Dentistry of Shiraz University of Medical Sciences, Ghasr o dasht street , Shiraz , Fars, Iran
City
Shiraz
Postal code
Phone
+98 71 1628 9917
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)